A prospective randomized controlled study with intermittent mechanical compression of the calf in patients with claudication

ObjectivesThe study tested the feasibility of using a new portable mechanical compression device for the treatment of claudication. The device applies intermittent non-pneumatic mechanical compression (IMC) to the calf. It was hypothesized that it can offer a low-cost convinient option for patients and achieve good compliance and improved clinical outcomes.MethodsThirty patients were enrolled in a randomized controlled single blind study. Fourteen patients were assigned to active IMC. Sixteen control patients continued with medical treatment alone. Outcomes were recorded at baseline, after one month, three months, and six months. The study examined changes in exercise tolerance using Initial Claudiacation Distance (ICD) and Absolute Claudiaction Distance (ACD) as well as ankle-brachial index at rest (ABI-r) and post-exercise (ABI-pe). All patients had stable claudication due to peripheral arterial disease (PAD) and were already under best medical treatment (BMT). To be eligible for inclusion, patients had to be between the ages of 50 and 75 years, had to have stable claudication with an absolute claudication distance >40 meters but <300 meters on a standardized treadmill stress test (3.8 km/h at a 10% grade), have a resting ABI in the affected limb <0.8 with a drop of at least 0.15 following exercise, in whom surgical intervention was not expected for at least three months. Fourteen patients were assigned to active IMC consisting of compressions 65 mm Hg in amplitude, applied for three 3-second compressions/minute, two hours/day for three months. Sixteen control patients continued with BMT alone.ResultsOne month after treatment, ICD increased by 66% (P = .001), ACD increased by 51.75% (P = .005), and ABI-pe increased by 42% (P = .01). Treatment effects were maintained or further improved after three months. ABI-r did not increase at any time. Compliance exceeded 80%. Three months following cessation of therapy, claudication distances and ABI-pe did not decrease significantly.ConclusionsWe concluded that the use of IMC of the calf for three months increased claudication distances and led to objective improvements in ABI-pe. Intermittent mechanical compression may be a useful approach to patients with continued claudication despite standard medical treatment

Relationship Between the Plasma Concentration of C-Reactive Protein and Severity of Peripheral Arterial Disease

Objective To determine whether the increase in plasma levels of C-Reactive Protein (CRP), a non-specific reactant in the acute-phase of systemic inflammation, is associated with clinical severity of peripheral arterial disease (PAD). Methods and Results This is a cross-sectional study at a referral hospital center of institutional practice in Madrid, Spain. A stratified random sampling was done over a population of 3370 patients with symptomatic PAD from the outpatient vascular laboratory database in 2007 in the order of their clinical severity: the first group of patients with mild chronological clinical severity who did not require surgical revascularization, the second group consisted of patients with moderate clinical severity who had only undergone only one surgical revascularization procedure and the third group consisted of patients who were severely affected and had undergone two or more surgical revascularization procedures of the lower extremities in different areas or needed late re-interventions. The Neyman affixation was used to calculate the sample size with a fixed relative error of 0.1. A homogeneity analysis between groups and a unifactorial analysis of comparison of medians for CRP was done. The groups were homogeneous for age, smoking status, Arterial Hypertension HTA, diabetes mellitus, dyslipemia, homocysteinemia and specific markers of inflammation. In the unifactorial analysis of multiple comparisons of medians according to Scheffe, it was observed that the median values of CRP plasma levels were increased in association with higher clinical severity of PAD (3.81 mg/L [2.14-5.48] vs. 8.33 [4.38-9.19] vs. 12.83 [9.5-14.16]; p < 0.05) as a unique factor of tested ones. Conclusion Plasma levels of CRP are associated with not only the presence of atherosclerosis but also with its chronological clinical severity

Treatment of thromboangiitis obliterans (Buerger's disease) with bosentan

<p>Abstract</p> <p>Background</p> <p>This study assessed the effectiveness and safety of bosentan when administered to thromboangiitis obliterans (Buerger's disease) patients.</p> <p>Methods</p> <p>A clinical pilot study was designed in which patients with ulcer and/or pain at rest were treated with bosentan p.o. at a dose of 62.5 mg twice daily during the first month, which was thereafter up-titrated to 125 mg twice daily. The study endpoints were clinical improvement rate, major or minor amputation rate, haemodynamic changes, changes in endothelial function and angiographic changes.</p> <p>Results</p> <p>Seven out of 12 patients were male (58%). Median age was 39 years (range 29-49). The median follow-up was 20 months (range 11-40). All patients were smokers. With bosentan treatment, new ischaemic lesions were observed in only one patient. Overall, clinical improvement was observed in 12 of the 13 extremities (92%). Only two out of 13 extremities underwent amputation (one major and one minor) after bosentan treatment. After being assessed by digital arteriography with subtraction or angio-magnetic resonance imaging, an increase of distal flow was observed in 10 out of the 12 patients. All patients experienced a statistically significant improvement in their BAFMD values (mean: 1.8 at baseline; 6.6 at the end of the treatment; 12.7 three months after the end of the treatment; p < 0.01).</p> <p>Conclusion</p> <p>Bosentan treatment may result in an improvement of clinical, angiographic and endothelial function outcomes. Bosentan should be investigated further in the management of TAO patients. Larger studies are required to confirm these results.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01447550">NCT01447550</a></p

Reducing the environmental impact of surgery on a global scale: systematic review and co-prioritization with healthcare workers in 132 countries

Abstract Background Healthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres. Methods This study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, ranked lists of interventions were presented by their relevance to high-income countries and low–middle-income countries. Results In phase 1, 43 interventions were identified, which had low uptake in practice according to 3042 professionals globally. In phase 2, a shortlist of 15 intervention domains was generated. In phase 3, interventions were deemed acceptable for more than 90 per cent of patients except for reducing general anaesthesia (84 per cent) and re-sterilization of ‘single-use’ consumables (86 per cent). In phase 4, the top three shortlisted interventions for high-income countries were: introducing recycling; reducing use of anaesthetic gases; and appropriate clinical waste processing. In phase 4, the top three shortlisted interventions for low–middle-income countries were: introducing reusable surgical devices; reducing use of consumables; and reducing the use of general anaesthesia. Conclusion This is a step toward environmentally sustainable operating environments with actionable interventions applicable to both high– and low–middle–income countries

Treatment of Buerger disease (thromboangiitis obliterans) with bosentan: a case report

Buerger disease (thromboangiitis obliterans) is a non-atherosclerotic segmental inflammatory disease strongly associated with tobacco use, and it affects small and medium-sized blood vessels in the upper and lower extremities. The only known treatment for this disease is complete discontinuation of tobacco use. This report describes the case history of a woman with Buerger disease treated with the oral dual endothelin receptor antagonist bosentan. It is believed that this is the first description in the literature of this use for bosentan

Chronic Ulcers in Thromboangiitis Obliterans (Buerger's Disease): Updating Epidemiology, Physiopathology, and Bosentan—A Novel Strategy of Therapy

Thromboangiitis obliterans (TAO) or Buerger's disease is associated with both distal ulcers in the extremities and the possibility of amputation. The only treatment that has been shown to be effective in TAO is complete abstention from smoking. In spite of this, the disease progresses in up to 30 percent of cases and finally results in limb amputation. Only a few pharmacological and surgical options are available to date to improve healing ulcers in TAO. The efficacy of prostaglandin analogues is controversial. This paper summarizes the current evidence for medical treatment with bosentan in chronic ulcers in TAO patients. These available data up to date allow us to conclude that the beneficial effects of bosentan on improving endothelial function, inflammatory processes, and selective vasodilatation of damaged vessels result in a clinical enhancement regarding healing and preventive digital ulcers in such patients. In any case, these promising findings have to be confirmed with larger randomised trials